Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a 'High' severity score (3) in the absence of reported injuries or fatalities, as the hazard is a manufacturing defect with remote probability of serious adverse health consequences.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling six units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS. The specific units affected are reference 99-0155/16, with a stem size of S-2, a proximal stem diameter of 16 mm, and a length of 180 mm. The affected lots are B225116 and B128075.
The recall was initiated because the trial stems were manufactured using the wrong design. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed in the United States to the state of Tennessee only. Consumers and healthcare providers who have these specific trial stems should stop using them and contact the manufacturer or their local FDA office for instructions on return or replacement.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: B225116
- B128075
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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- HighWaldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
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